Tag Archives: Health Canada

OECD’s (Organization for Economic Cooperation and Development) latest report on its regulating manufactured nanomaterials questionnaire

As I have commented on several occasions, most of my information about Canada’s activities with regard to risk and nanomaterials comes from outside the country, notably the OECD (Organization for Economic Cooperation and Development).

Thank’s to Lynn Bergeson and her Sept. 17, 2014 posting on Nanotechnology Now for information about the latest publication from the OECD’s Working Party on Manufactured Nanomaterials (Note: a link has been removed),

On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. … The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the oversight of nanomaterials in various OECD jurisdictions: regulatory updates; definitions and/or legal approaches for nanomaterials by jurisdiction; regulatory challenges; and opportunities for collaboration.

You can find all of the reports from the OECD’s WPMN here, including this latest report, which is no. 42, Report of the questionnaire on regulatory regimes for manufactured nanomaterials 2010-201, ENV/JM/MONO(2014)28. This is the third time there’s been a questionnaire and subsequent report.

I have quickly skimmed through the report and found a few interesting items about Canada’s current activities and collaborations vis à vis manufactured nanomaterials and risk. From the REPORT OF THE QUESTIONNAIRE ON REGULATORY REGIMES FOR MANUFACTURED NANOMATERIALS 2010-2011 which appears to have been published Sept. 4, 2014. I have had an unusually difficult time including excerpts from the report along with page numbers, etc. On the first try, after almost an hour of cutting and pasting, I was unable to get an intelligible version into a preview. To all intents and purposes the text was in place but the preview attempt resulted in a bizarre column of text overwriting the sidebar to the right of the posts.

I tried again and found that extensive reformatting was necessary and that the original table format has been lost. Nonetheless. you will find there are two pieces of legislation being reported on, CEPA (1999), which I believe has something to do with Environment Canada, and F&DA, which seems to be associated with Health Canada. One or both pieces of legislation may be referenced as per the OECD report. Page numbers from the document are included after the excerpted table entries.

Table 12: Hazard identification …

CEPA (1999)

Extrapolation between nanomaterials (i.e., choosing the appropriate surrogate)

Validity of testing methods and analytical tools to detect, characterize and measure nanomaterials

Participating in international forums such as the WPMN [OECD Working Party on Manufactured Nanomaterials], Expert Meetings, and ISO [International Standards Organization] TC/229 to support the generation and synthesis of appropriate science.

Support domestic research to help minimize challenges in hazard identification.

F&DA

Nanomaterial-based products under the F&DA (i.e. nanomedicines) can be associated with a broad spectrum of toxicities that are dependent on the nanoparticle properties (e.g. size, surface charge and solubility). However, there is currently no specific guidance document available for nanomedicines. Nanoparticle properties can significantly impact the PK profile/biodistribution of nanomedicines resulting in safety concerns. The components of the nanomedicines can also interact with the immune system and may trigger unique immunogenicity/immunotoxicity profile. Animals are generally not predictive of immunological responses for biologics (however, it may not be the case if the nanomedicine is a chemical drug), it is likely that immunological studies for nanomedicines should be carried out in human clinical trials. Long term studies may be required for a nanomaterial that persist and accumulated in particular tissues for an extended period of time.  p. 45

Table 13: Health and safety …

F&DA Veterinary Drugs

Due to the lack of a comprehensive understanding of the effects of nanomaterials on human, animal and environmental health, the Veterinary Drugs Directorate has not yet established a comprehensive occupational health and safety policy. Moreover, occupational health and safety is a shared responsibility between the federal and provincial governments in Canada.

At this time, there is no conclusive evidence linking exposure of nanomaterials from veterinary drugs or food sources to negative impact on human health. Additional research is necessary before a definitive policy approach can be taken.

F&DA Veterinary Drugs
Veterinary drugs including those that contain nanomaterials are regulated by the Food and Drugs Act and the Food and Drug Regulations. These provide the Veterinary Drugs Directorate with the authority to regulate the human health and safety aspects of veterinary drug products. The Regulations cover the aspects of the manufacturing, human and animal safety and efficacy assessment, and post-market surveillance of veterinary drug products including those containing nanomaterials. The latter products are subject to the same rigorous assessments as non-nanomaterial-containing veterinary drug products. p. 47

Table 14: Risk Assessment Methodologies

CEPA (1999)

Our understanding of risk assessments of nanomaterials is still evolving. Nanomaterials regulated under the industrial chemicals program employ a precautionary approach (i.e., exposure is typically mitigated), and nano-relevant information is requested whenever appropriate to conduct more informed risk assessments.

Canada also continues to work in international projects, such as the international life sciences institute NanoRelease project aimed at developing methods to quantify releases of nanomaterials from solid matrices.

Canada is also part of the Regulatory Cooperation Council (RCC) Nanotechnology Initiative with the United States. Under this project, Canada and the US are developing a classification scheme for nanomaterials to inform on the utilization of analogue/read- across, developing frameworks and common assumptions to better
inform risk assessments, and mining public and confidential use information to increase marketplace knowledge of nanomaterials. p. 49

Table 15: Risk Management and Nanomaterials in Commerce …

CEPA (1999)

Knowledge of use profiles of industrial nanomaterials; lack of specificity in risk
management measures given the overall lack of information and nomenclature systems for nanomaterials

Under the RCC, Canada and the US are gathering information on the uses of industrial nanomaterials in the two countries.  p. 52

Table 16: Research … (to support regulatory decisions)

CEPA (1999)

– foster domestic and international capacity to generate research on risk assessment priorities and needs
– applying research findings to nanomaterial risk assessments
– using research on nanomaterials to extrapolate to other nanomaterials

– Canada is actively supporting domestic and international research projects to help inform risk assessments.

F&DA

Filling knowledge gaps

HC [Health Canada] is conducting laboratory research to study the effects of lipid nanoparticles on the thermal stability of various recombinant proteins with the aim of identifying determinants of susceptibility to unintended deleterious interactions.  p. 55

Table 17: Impact of Regulatory Actions and Innovations and Economic Growth

CEPA (1999)

How to obtain the necessary information on nanomaterials, and how to regulate them in a manner that does not prevent them from offering their many benefits to society.

Consult with industry on proposed approaches. Focus information requests and requirements.  pp. 56/7

Table 18: Labelling Communication of Nanomaterials …

CEPA (1999)

Labelling of nanomaterials has not been considered under CEPA 1999 to date. p. 58

Table 19: Collaboration with other countries …

CEPA (1999) & F&DA

New Substances Program is involved in various international activities, including:
1) International Organization for Standardization (ISO) Technical Committee (TC) 229 on Nanotechnologies
2) Organisation for Economic Co-operation and Development (OECD) Working Party on
Manufactured Nanomaterials (WPMN) and Working Party on Nanotechnology (WPN)
3) Canada-US Regulatory Cooperation Council (RCC)
4) International Cooperation on Cosmetic Regulation (ICCR) – 2 Reports have been published
a) Criteria and Methods of Detection for Nanomaterials in Cosmetics:

http://www.fda.gov/downloads/InternationalPrograms/HarmonizationInitiatives/UCM235485.pdf

b) Methods for Characterization of Nanomaterials in Cosmetics

http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/iccr5_char_nano_en.pdf

5) International Regulators Nanotechnology Working Group
6) International Life Sciences Institutes (ILSI) – NanoRelease Food Additive Project
7) NanoLyse

In addition, for veterinary drugs, Health Canada collaborates with other regulatory agencies in USA, Europe, Australia, etc in the regulation of non-nanomaterial products and substances and would do the same for substances that are, or products containing nanomaterials pp. 59/60

Table 19: Expert Workshop Sponsorship [table number repetition noted]

CEPA (1999)

The Workshop on the Human and Environmental Risk Assessment of Nanomaterials convened by Health Canada and Environment Canada (March 24-26, 2010) provided an open forum for detailed dialogue on nanomaterials among science evaluators, research scientists and regulators. The Workshop was attended by 25 experts from Australia, Canada, Europe, Korea and the United States of America. In addition, seven observers attended the Workshop.

Regulatory Cooperation Council with the United States

F&DA Foods

Health Canada will be hosting a Joint NanoLyse/NanoRelease Workshop to discuss methods and safety of nanomaterials and share information from the respective projects. NanoLyse is an EU research consortium to develop methods of analysis for engineered nano-materials in foods and NanoRelease is an International Life Sciences Institute lead initiative to develop of analytical methods, alimentary canal models for uptake of engineered nano-materials and review of regulatory issues. p. 61

In any event, good luck with the reading and you can find out more about NanoLyse here and more about Canadian participation in the NanoRelease Food Additive Steering Committee project here.

Treatment for patients infected with the ebola virus (a response to crisis in West African countries)

I’ve not actively kept up with the situation in the West African countries suffering an outbreak of the ebola virus other than to note that it is ongoing. My Aug. 15, 2014 post provides a snapshot of the situation and various new treatments, including one based on tobacco, which could be helpful but appeared not to have been tested and/or deployed. There was a lot of secrecy (especially from Medicago, a Canadian company) regarding the whole matter of treatments and vaccines.

There seem to have been some new developments on the treatment side, involving yet another Canadian company, Tekmira, according to a Sept. 23, 2013 news item on Azonano,

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference (RNAi) therapeutics, today announced that the FDA [US Food and Drug Administration] has authorized Tekmira to provide TKM-Ebola for treatment under expanded access protocols to subjects with confirmed or suspected Ebola virus infections.

A Sept. 22, 2014 Tekmira news release, which originated the news item, expands on the topic of regulatory issues associated with bringing this treatment to the areas suffering the outbreak,

“Tekmira is reporting that an appropriate regulatory and clinical framework is now in place to allow the use of TKM-Ebola in patients. We have worked with the FDA and Health Canada to establish this framework and a treatment protocol allowing us to do what we can to help these patients,” said Dr. Mark J. Murray Tekmira’s President and CEO.

“We have insisted on acting responsibly in the interest of patients and our stakeholders,” added Dr. Murray. “Today we are reporting that, working closely with regulators in the United States and Canada, we have established a framework for TKM-Ebola use in multiple patients. In the US, the FDA has granted expanded access use of TKM-Ebola under our Investigational New Drug application (IND) and Health Canada has established a similar framework, both of which allow the use of our investigational therapeutic in more patients.”

“We have already responded to requests for the use of our investigational agent in several patients under emergency protocols, in an effort to help these patients, a goal we share with the FDA and Health Canada. TKM-Ebola has been administered to a number of patients and the repeat infusions have been well tolerated. However, it must be kept in mind that any uses of the product under expanded access, does not constitute controlled clinical trials. These patients may be infected with a strain of Ebola virus which has emerged subsequent to the strain that our product is directed against, and physicians treating these patients may use more than one therapeutic intervention in an effort to achieve the best outcome,” said Dr. Murray. “Our TKM-Ebola drug supplies are limited, but we will continue to help where we can, as we continue to focus on the other important objectives we have to advance therapies to meet the unmet needs of patients.”

TKM-Ebola is an investigational therapeutic, being developed under an FDA approved IND, which is currently the subject of a partial clinical hold under which the FDA has allowed the potential use of TKM-Ebola in individuals with a confirmed or suspected Ebola virus infection.

About FDA Expanded Access Program

Expanded access is the use of an investigational drug outside of a clinical trial to treat a patient, with a serious or immediately life-threatening disease or condition, who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial. (Source: www.fda.com)

About TKM-Ebola, an Anti-Ebola Virus RNAi Therapeutic

TKM-Ebola, an anti-Ebola virus RNAi therapeutic, is being developed under a $140 million contract with the U.S. Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office. Earlier preclinical studies were published in the medical journal The Lancet and demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira’s LNP [Lipid Nanoparticle] technology were used to treat previously infected non-human primates, the result was 100 percent protection from an otherwise lethal dose of Zaire Ebola virus (Geisbert et al., The Lancet, Vol. 375, May 29, 2010). In March 2014, Tekmira was granted a Fast Track designation from the U.S. Food and Drug Administration for the development of TKM-Ebola.

About Joint Project Manager Medical Countermeasure Systems (JPM-MCS)

This work is being conducted under contract with the U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems (JPM-MCS). JPM-MCS, a component of the Joint Program Executive Office for Chemical and Biological Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance biodefense response capability. For more information, visit www.jpeocbd.osd.mil.

About Tekmira

Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle (LNP) delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmira.com. Tekmira is based in Vancouver, B.C. Canada.

Forward-Looking Statements and Information

This news release contains “forward-looking statements” or “forward-looking information” within the meaning of applicable securities laws (collectively, “forward-looking statements”). Forward-looking statements in this news release include statements about Tekmira’s strategy, future operations, clinical trials, prospects and the plans of management; an appropriate regulatory and clinical  framework for emergency use of TKM-Ebola in subjects with confirmed or suspected Ebola infections; FDA grant of expanded access use of TKM-Ebola under Tekmira’s IND; Health Canada’s establishment of a similar framework for TKM-Ebola; Tekmira’s response to requests for the use of TKM-Ebola in several patients under emergency protocols and the results thereon; the current supply of TKM-Ebola drug; the partial clinical hold on the TKM-Ebola IND by the FDA (enabling the potential use of TKM-Ebola in individuals with a confirmed or suspected Ebola virus infection); the quantum value of the contract with the JPM-MCS; and Fast Track designation from the FDA for the development of TKM-Ebola.

With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things, the clinical framework for emergency use of TKM-Ebola. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.

Additionally, there are known and unknown risk factors which could cause Tekmira’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: TKM-Ebola may not prove to be effective in the treatment of Ebola infection under the emergency use framework, or at all; any uses of TKM-Ebola under emergency INDs are not controlled trails, and TKM-Ebola may be used on Ebola strains that have diverged from the strain to which TKM-Ebola is directed, and physicians treating patients may use more than one therapeutic intervention in addition to TKM-Ebola; the current supply of TKM-Ebola is limited, and Tekmira may not be able to respond to future requests for help in the current Ebola outbreak; the FDA may not remove the partial clinical hold on the TKM-Ebola IND; the FDA may refuse to approve Tekmira’s products, or place restrictions on Tekmira’s ability to commercialize its products; anticipated pre-clinical and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; and Tekmira may not receive the necessary regulatory approvals for the clinical development of Tekmira’s products.

A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s Annual Report on Form 10-K and Tekmira’s continuous disclosure filings, which are available at www.sedar.com or www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

In the midst of all those ‘cover your rear end’ statements to investors, it’s easy to miss the fact that people are actually being treated and the results are promising, if not guaranteed,

Tekmira has distributed a Sept. 23, 2014 news release touting its membership in a new consortium, which suggests that in parallel with offering treatment, human clinical trials will  also be conducted,

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today reported that it is collaborating with an international consortium to provide an RNAi based investigational therapeutic for expedited clinical studies in West Africa.

Led by Dr. Peter Horby of the Centre for Tropical Medicine and Global Health at the University of Oxford and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), the consortium includes representatives from the World Health Organization (WHO), US Centers for Disease Control, Médecins Sans Frontières – Doctors without Borders (MSF), ISARIC, and Fondation Mérieux, among others.

The Wellcome Trust has announced it has awarded £3.2 million to the consortium to fund this initiative. The award will include funds for the manufacture of investigational therapeutics as well as the establishment of an operational clinical trials platform in two or more Ebola Virus Disease (EVD) treatment centers in West Africa. RNAi has been prioritized as an investigational therapeutic and may be selected for clinical trials at these centers.

The objective of the clinical trials is to assess the efficacy and safety of promising therapeutics and vaccines, reliably and safely, in patients with EVD by adopting strict protocols that comply with international standards.  It is hoped this initiative will permit the adoption of safe and effective interventions rapidly.

The genetic sequence of the Ebola virus variant responsible for the ongoing outbreak in West Africa is now available. Under this program, Tekmira will produce an RNAi based product specifically targeting the viral variant responsible for this outbreak.  The ability to rapidly and accurately match the evolving genetic sequences of emerging infectious agents is one of the powerful features of RNAi therapeutics.

“We commend the Wellcome Trust for their leadership in providing the necessary funds to launch and expedite this ground breaking initiative. We are gratified that RNAi has been prioritized as a potential investigational therapeutic to assist in the ongoing public health and humanitarian crisis in Africa,” said Dr. Murray, Tekmira’s President and CEO.

“We are an active collaborator in this consortium and through our ongoing dialogue with the WHO, NGOs and governments in various countries; we have been discussing the creation of appropriate clinical and regulatory frameworks for the potential use of investigational therapeutics in Africa. This initiative goes a long way towards achieving this aim.  Many complex decisions remain to fully implement this unique clinical trial platform.  At this time, there can be no assurances that our product will be selected by the consortium for clinical trials in Africa,” said Dr. Murray.

About Wellcome Trust

The Wellcome Trust is the largest charity in the UK. It funds innovative biomedical research, in the UK and internationally, spending over £600 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing. For more information, visit www.wellcome.ac.uk

I’m glad they’re being careful while giving people treatment, i. e., trying to do something rather than waiting to conduct human clinical trials as has sometimes been the case in the past. This business of running the trials almost parallel to offering treatment suggests an agility not often associated with the international health care community.

ETA Sept. 23 2014 1200 hours PDT: For more information about the status of the Ebola outbreak read Tara Smith’s Sept. 22, 2014 article Slate titled, Here’s Where We Stand With Ebola; Even experienced international disaster responders are shocked at how bad it’s gotten (Note: Links have been removed).

Now, terms like “exponential spread” are being thrown around as the epidemic continues to expand more and more rapidly. Just last week, an increase of 700 new cases was reported, and the case count is now doubling in size approximately every three weeks.

A Doctors Without Borders worker in Monrovia, Liberia, named Jackson Naimah describes the situation in his home country, noting that patients are literally dying at the front door of his treatment center because it lacks patient beds and assistance; the sufferers are left to die a “horrible, undignified death” and potentially infect others as they do so: …

… Health care workers who are treating the sick are dying because they also lack basic protective equipment, or because they have been so overwhelmed by taking care of the ill and dying that they begin to make potentially fatal errors. They have gone on strike in Liberia because they are not being adequately protected or even paid for their risky service.

Fear and misinformation are as deadly as the virus itself. Eight Ebola workers were recently murdered in Guinea, in the area where the virus first came to the world’s attention in March. Liberia’s largest newspaper featured a story describing Ebola as a man-made virus being purposely unleashed upon Africans by Western pharmaceutical companies. Reports abound of doctors and other workers being chased away, sometimes violently, by fearful families. …

It’s not a pleasant read but, I think, a necessary one. For anyone who may think the panic and fear are unique to this situation, I once worked with a nurse who described being lifted by her neck after someone came through the door of a clinic demanding a vaccine and had been refused. He was in such a panic and so fearful he wasn’t going to take a ‘no’. The incident took place in Vancouver (Canada) in a ‘nice’ part of town.

ETA Sept. 24, 2014: Kelly Grant has written a Sept. 22, 2014 article for the Globe and Mail which provides more information about Tekmira, some of which contradicts the details I have here about TKM-Ebola and clinical trials in Africa although the key points remain the same. She also provides more information about the ZMapp therapy (mentioned in my Aug. 15, 2014 post) noting yet a third Canadian connection.* Canada’s National Microbiology Laboratory was somehow involved in developing ZMApp, unfortunately, Grant does not or is not able to provide more details about that involvement.

ETA Oct. 16, 2014: David Bruggeman recommends a digital journalism site Ebola Deeply for some in depth reporting in his Oct. 16, 2014 posting.

* This sentence “She also provides more information about the ZMapp therapy mentioned in my Aug. 15, 2014 post mentioning yet a third Canadian connection.” was altered for grammatical purposes on Dec. 4, 2014.

Deadline extension (travel grants and poster abstracts) for alternate testing strategies (ATS) of nanomaterials workshop

It seems there have been a couple of deadline extensions (to August 1, 2014) for the September 15-16, 2014 ‘Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials’ in Washington, DC (first mentioned in my July 10, 2014 posting featuring a description of the workshop). You can go here to submit a poster abstract (from any country) and you can go here if you’re a student or young professional (from any country) in search of a $500 travel award.

I managed to speak to one of the organizers, Lorraine Sheremeta, (Assistant Director, Ingenuity Lab, University of Alberta and co-author a July 9, 2014 Nanowerk Spotlight article about the workshop). Lorraine (Lori) kindly spoke to me about the upcoming workshop, which she described as an academic conference,.

As I understand what she told me, the hosts for the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC want to attract a multidisciplinary group of people to grapple with a few questions. First, they want to establish a framework for establishing which are the best test methods for nanomaterials. Second, they are trying to move away from animal testing and want to establish which methods are equal to or better than animal testing. Thirdly, they want to discuss what they are going to do with the toxicological data  that we have  been collecting on nanomaterials for years now.

Or, as she and her colleague from the Society of Risk Analysis (Jo Anne Shatkin) have put in it in their Nanowerk Spotlight article:

… develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS [alternate testing strategies] methods in a database; and develop a case study to inform workshop deliberations and expert recommendations

The collaborative team behind this event includes, the University of Alberta’s Ingenuity Lab, the Society for Risk Analysis, Environment Canada, Health Canada, and the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) .

The speaker lineup isn’t settled at this time although they have confirmed Vicki Stone of Heriot-Watt University in Scotland (from her university bio page),

Vicki Stone, Professor of Toxicology, studies the effects of nanomaterials on humans and environmentally relevant species.  Current research projects investigate the mechanism of toxicity of a range of nanomaterials in cells of the immune system (macrophages and neutrophils), liver (hepatocytes) , gastrointestinal tract, blood vessels (endothelium) and lung.  She is interested in interactions between nanomaterials, proteins and lipids, and how this influences subsequent toxicity.  Current projects also develop in vitro alternatives using microfluidics as well as high resolution imaging of individual nanomaterials in 3D and over time.  In addition Vicki collaborates with ecotoxicologists to investigate the impacts of nanomaterials on aquatic organisms. Vicki coordinated a European project to identify the research priorities to develop an intelligent testing strategy for nanomaterials (www.its-nano.eu).

Vicki is Director of the Nano Safety Research Group at Heriot-Watt University, Edinburgh, and Director of Toxicology for SAFENANO (www.safenano.org). She has acted as the Editor-in-chief of the journal Nanotoxicology (http://informahealthcare.com/nan) for 6 years (2006-2011). Vicki has also published over 130 publications pertaining to particle toxicology over the last 16 years and has provided evidence for the government commissioned reports published by the Royal Society (2003) and the on Environmental Pollution (2008).  Vicki was previously a member of the UK Government Committee on the Medical Effects of Air Pollution (COMEAP) and an advisory board member for the Center for the Environmental Implications of NanoTechnology (CEINT; funded by the US Environmental Protection Agency)).

A representative from PETA (People for the Ethical Treatment of Animals) will also be speaking. I believe that will be Amy Clippinger (from the PETA website’s Regulatory Testing webpage; scroll down about 70% of the way),

Science adviser Amy Clippinger has a Ph.D. in cellular and molecular biology and genetics and several years of research experience at the University of Pennsylvania.

PETA representatives have been to at least one other conference on the topic of nano, toxicology, and animal testing as per my April 24, 2014 posting about NANOTOX 2014 in Turkey,

Writing about nanotechnology can lead you in many different directions such as the news about PETA (People for the Ethical Treatment of Animals) and its poster presentation at the NanoTox 2014 conference being held in Antalya, Turkey from April 23 – 26, 2014. From the April 22, 2014 PETA news release on EurekAlert,

PETA International Science Consortium Ltd.’s nanotechnology expert will present a poster titled “A tiered-testing strategy for nanomaterial hazard assessment” at the 7th International Nanotoxicology Congress [NanoTox 2014] to be held April 23-26, 2014, in Antalya, Turkey.

Dr. Monita Sharma will outline a strategy consistent with the 2007 report from the US National Academy of Sciences, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” which recommends use of non-animal methods involving human cells and cell lines for mechanistic pathway–based toxicity studies.

There is a lot of interest internationally in improving how we test for toxicity of nanomaterials. As well, the drive to eliminate or minimize as much as possible the use of animals in testing seems to be gaining momentum.

Good luck to everyone submitting a poster abstract and/or an application for a travel grant!

In case you don’t want to scroll up, the SRA nano workshop website is here.

Canada-US joint Regulatory Cooperation Council nanotechnology initiative completed and Canada endorses OECD nanomaterials recommendation

Thanks to Lynn Bergeson’s July 9, 2014 posting on Nanotechnology Now, I learned the Canada-US joint Regulatory Cooperation Council (RCC) nanotechnology initiative has completed its work and will be filing final reports later this summer (2014).

I have featured the RCC here in at least three postings, a Dec. 3, 2012 posting, a June 26, 2013 posting, and a January 21, 2014 posting. Briefly, the RCC was first announced in 2011 and is intended to harmonize Canadian and US regulatory frameworks in a number of areas including, agriculture and food, transportation, personal care products and pharmaceuticals and more. Significantly, nanotechnology was also part of their portfolio.

The latest information about RCC doings was obtained from the Canadian government’s 2014 summer issue of the Chemicals Management Plan (CMP) Progress Report (a second thank you for Bergeson for information about this publication),

The Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative is now complete. Canada and the U.S. are implementing the new approaches and lessons learned in risk assessments of nanomaterials. An important outcome of the initiative is the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by the Government of Canada. Watch for the publication of the final reports from the Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative this summer. The reports will include recommendations about ways in which Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.

The 2014 CMP summer issue offers a second tidbit of information. This time it’s about Canada and the OECD,

Canada has endorsed a recommendation from the Organisation for Economic Co-operation and Development’s Council on the Safety Testing and Assessment of Manufactured Nanomaterials. The recommendation states that countries “apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials.” The recommendation was based on the work of the Organisation for Economic Co-operation and Development’s Working Party on Manufactured Nanomaterials, which is a harmonization effort to inform regulatory programs regarding the environmental and health and safety implications of manufactured nanomaterials.

For enthusiasts, Canada’s Chemicals Management Plan progress report is expected to be published twice/year. There are now two issues available, the first with a Dec. 30, 2013 publication date. Here’s more about the CMP progress reports,

The Chemicals Management Plan Progress Report has been created to keep stakeholders and other interested parties up to date on the activities and programs related to Canada’s Chemicals Management Plan (CMP). The report is produced jointly by Environment Canada and Health Canada and will be published twice a year. It will report on advances in major initiatives and highlight key activities related to the Government of Canada’s recent work under the CMP. It will also inform you about coming events, dates of interest and how to get involved.

We encourage you to share the reports with anyone who may be interested. We also welcome your feedback or suggestions. We can be reached at [email protected]

Anyone interested in more information about the RCC (Regulatory Cooperation Council) and its nanotechnology efforts can find it here.

An upcoming alternate testing strategies (ATS) for nanomaterials workshop and the quest to reduce animal testing

It’s too late to announce a call for poster abstracts or travel awards but that still leaves the possibility of attending a September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC. In a July 9, 2014 Nanowerk Spotlight article,, Jo Anne Shatkin (President, Vireo Advisors) and Lorraine Sheremeta (Assistant Director, Ingenuity Lab, University of Alberta) tout the workshop in the context of describing new approaches to nanotoxicology research (Note: A link has been removed),

Engineered nanoscale materials (ENM or ‘nanomaterials’) offer the potential to create safer and more effective products through the use of smaller quantities of improved performance materials. Currently nanomaterials are used to improve the performance of life-saving drugs and medical technologies, to make renewable energy more efficient, to make value added products from industrial waste streams, to improve food, packaging, to lightweight materials used in transportation systems, and to improve many of the personal care products that we use every day. Nanomaterial manufacture and use is expected to increase over the coming years and despite the widespread use of nanomaterials in a variety of consumer products, we are only beginning to understand the impacts of these emerging materials on our health and the environment. To this end, the University of Alberta’s Ingenuity Lab is collaborating with the Society for Risk Analysis to evaluate the potential to use alternative test strategies (ATS) to improve our ability to assess nanomaterial toxicity and environmental impact.

Shatkin and Sheremeta describe toxicology tests and explain the importance of refining and improving these tests (from the article),

Standard in vivo toxicology test methods that depend heavily on the use of animals have long been used to assess chemical safety. [emphasis mine*] Existing and novel in vitro and in silico test methods provide important alternatives to in vivo animal testing for chemicals and potentially for ENM. Genotoxicity tests, for example, are used to assess the mutagenic potential of chemicals or nanomaterials in the replication of DNA in cells. Driven in part by increasing market and regulatory requirements for safer and more sustainable products, large international infrastructure has developed for creating, testing and validating in vitro test methods, and its use is expanding to chemical and nanomaterial assessment (NSF, 2007). The goals of reducing, refining and replacing animal testing (the commonly cited ‘three Rs’) – resonate with key and diverse stakeholders including animal rights groups, the bioethics community, the pharmaceutical industry, regulatory agencies and the broader public. [emphasis mine*]

Despite nearly a decade of effort in the conduct toxicology and exposure research to inform the assessment of health and environmental risks of nanomaterials, major gaps remain in the ability to understand and quantify risks. While there is now a large body of published data on carbon nanotubes and metal oxide nanoparticles, concern has been raised that speculation about nanomaterial risk has hardened into an assumption that there are ‘as-yet-to-be-discovered risks’ that we must identify and manage (Maynard, 2014) that demands extensive testing.

The authors describe ATS (alternative test strategies) in greater detail,

ATS approaches are regarded by many to have the potential for rapid screening of large numbers and types of materials. They can include a breadth of techniques including high throughput screening methods (HTS), high content screening, computational approaches, toxicogenomics, cell-based methods, in vitro assays and non-mammalian whole animal models. The emergence of ATS raises questions about how the results of these methods may be used for assessing the potential risks of ENM. For instance, ATS could be used in combination in a multiple models approach to evaluate new ENM in a number of rapid assays and compare with well-studied substances using in vivo testing; thereby identifying ENM for additional testing in a more strategic fashion than is possible through conventional testing approaches.

They also describe the current state of affairs with ATS,

In the United States, the U.S. ToxCast program has, as part of their 21st century toxicity screening program (NRC, 2007), tested 29 NMs with 62 in vitro test methods (Wang et al. 2013). Many researchers, including several from the University of Alberta, have proposed and developed ATS to include a variety of methods, some which are standardized for chemicals, and others which take advantage of developments including advanced biological mechanistic understanding, genomics, metabolomics, automation and informatics. However, these existing as well as emerging ATS have a short history with nanomaterials, and have not yet proven to be reliable for quantitative estimation of ENM risk. Still, several international efforts have developed ATS that have potential to be used for screening purposes, and to guide further testing priorities for regulatory decision making. The goal of the September [2014] workshop by the Society for Risk Analysis is to explore ways in which distinct ATS may be used for screening and prioritizing the need for more extensive testing of novel ENM.

The parties (including the authors of the article) involved in developing this risk workshop are listed, also mentioned are members of the international testing scene,

Lori Sheremeta, the Assistant Director of Ingenuity Lab in Edmonton Alberta and past Chair of the Society for Risk Analysis (SRA) Emerging Nanoscale Materials Specialty Group (ENMSG), is collaborating with U.S.-based nanomaterials risk expert Jo Anne Shatkin (an SRA Councilor and co-founder of the SRA ENMSG), Environment Canada, Health Canada, the SRA ENMSG and others on a Pilot Project with the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) to develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS methods in a database; and develop a case study to inform workshop deliberations and expert recommendations.

There are many international efforts to develop, as well as to validate and standardize, these methods for chemicals, including organizations such as the US National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM), the European Union Reference Laboratory European Centre for the Validation of Alternative Methods (EURL ECVAM), the Japanese Center for the Validation of Alternative Methods (JacVAM), the Korean Centre for the Validation of Alternative Methods (KoCVAM) and the OECD. There is wide recognition that the diversity of NMs renders it impractical to use traditional animal testing to evaluate safety, hence there is significant interest in assessing the performance of both existing and emerging alternative testing strategies for NMs. Further, the EU directive REACH (Directive 2006/121/EC) requires replacing in vivo testing, and there is widespread popular agreement about the desire to limit animal testing. Finally, there is a need for more biologically informative toxicology methods (Hartung, 2010; Silbergeld et al, 2011; Landsiedel et al, 2009).

A list of the workshop objectives is offered  in the article,

The main objectives of the workshop are to:

assess the state of the science on HTS and ATS from a ‘multiple models’ perspective to identify areas of common findings from differing approaches, areas of greatest uncertainty, and priorities for follow up in applied research toward risk assessment of ENM;
evaluate the ability to use data from ATS/HTS methods for screening purposes – combining suites of assays and comparing well-studied substances to novel ones;

assess the ability to use a suite of ATS methods to amplify the Weight of Evidence;

characterize uncertainty associated with predictive relationships and propose strategies to address uncertainties;

elicit the perspectives of diverse stakeholders about the use of HTS/ATS for screening purposes in risk analysis of ENM; and

develop a set of recommendations for these alternative approaches to become more widely adopted for environmental, health and safety decision making about ENM across the product life cycle. The output of the workshop holds potential for transformation through risk screening approaches that promote safer and more sustainable material and technology development.

You can find more about the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC here.

The text in the article is a bit rough. Some of the ideas and topics don’t follow each other logically. So, be prepared to spend a little time reading, Happily, there are references included with the article.

I last mentioned Jo Anne Shatkin here in the context of a 2013 paper on alternative test strategies (ATS) in an Aug. 22, 2013 posting. I think the most recent mention of Lorraine Sheremeta here is in a Jan. 11, 2010 posting about Canada, nanotechnology, and food.

Final note, I am hoping to get some more information about the workshop and ATS scene from Lorraine Sheremeta to be published in a subsequent posting.

* I added the emphases at 0830 hours PDT July 10, 2014.

Does digitizing material mean it’s safe? A tale of Canada’s Fisheries and Oceans scientific libraries

As has been noted elsewhere the federal government of Canada has shut down a number of Fisheries and Oceans Canada libraries in a cost-saving exercise. The government is hoping to save some $440,000 in the 2014-15 fiscal year by digitizing, consolidating, and discarding the libraries and their holdings.

One would imagine that this is being done in a measured, thoughtful fashion but one would be wrong.

Andrew Nikiforuk in a December 23, 2013 article for The Tyee wrote one of the first articles about the closure of the fisheries libraries,

Scientists say the closure of some of the world’s finest fishery, ocean and environmental libraries by the Harper government has been so chaotic that irreplaceable collections of intellectual capital built by Canadian taxpayers for future generations has been lost forever.

Glyn Moody in a Jan. 7, 2014 post on Techdirt noted this,

What’s strange is that even though the rationale for this mass destruction is apparently in order to reduce costs, opportunities to sell off more valuable items have been ignored. A scientist is quoted as follows:

“Hundreds of bound journals, technical reports and texts still on the shelves, presumably meant for the garbage or shredding. I saw one famous monograph on zooplankton, which would probably fetch a pretty penny at a used science bookstore… anybody could go in and help themselves, with no record kept of who got what.”

Gloria Galloway in a Jan. 7, 2014 article for the Globe and Mail adds more details about what has been lost,

Peter Wells, an adjunct professor and senior research fellow at the International Ocean Institute at Dalhousie University in Halifax, said it is not surprising few members of the public used the libraries. But “the public benefits by the researchers and the different research labs being able to access the information,” he said.

Scientists say it is true that most modern research is done online.

But much of the material in the DFO libraries was not available digitally, Dr. Wells said, adding that some of it had great historical value. And some was data from decades ago that researchers use to determine how lakes and rivers have changed.

“I see this situation as a national tragedy, done under the pretext of cost savings, which, when examined closely, will prove to be a false motive,” Dr. Wells said. “A modern democratic society should value its information resources, not reduce, or worse, trash them.”

Dr. Ayles [Burton Ayles, a former DFO regional director and the former director of science for the Freshwater Institute in Winnipeg] said the Freshwater Institute had reports from the 1880s and some that were available nowhere else. “There was a whole core people who used that library on a regular basis,” he said.

Dr. Ayles pointed to a collection of three-ringed binders, occupying seven metres of shelf space, that contained the data collected during a study in the 1960s and 1970s of the proposed Mackenzie Valley pipeline. For a similar study in the early years of this century, he said, “scientists could go back to that information and say, ‘What was the baseline 30 years ago? What was there then and what is there now?’ ”

When asked how much of the discarded information has been digitized, the government did not provide an answer, but said the process continues.

Today, Margo McDiarmid’s Jan. 30, 2014 article for the Canadian Broadcasting Corporation (CBC) news online further explores digitization of the holdings,

Fisheries and Oceans is closing seven of its 11 libraries by 2015. It’s hoping to save more than $443,000 in 2014-15 by consolidating its collections into four remaining libraries.

Shea [Fisheries and Oceans Minister Gail Shea] told CBC News in a statement Jan. 6 that all copyrighted material has been digitized and the rest of the collection will be soon. The government says that putting material online is a more efficient way of handling it.

But documents from her office show there’s no way of really knowing that is happening.

“The Department of Fisheries and Oceans’ systems do not enable us to determine the number of items digitized by location and collection,” says the response by the minister’s office to MacAulay’s inquiry. [emphasis mine]

The documents also that show the department had to figure out what to do with 242,207 books and research documents from the libraries being closed. It kept 158,140 items and offered the remaining 84,067 to libraries outside the federal government.

Shea’s office told CBC that the books were also “offered to the general public and recycled in a ‘green fashion’ if there were no takers.”

The fate of thousands of books appears to be “unknown,” although the documents’ numbers show 160 items from the Maurice Lamontagne Library in Mont Jolie, Que., were “discarded.”  A Radio-Canada story in June about the library showed piles of volumes in dumpsters.

And the numbers prove a lot more material was tossed out. The bill to discard material from four of the seven libraries totals $22,816.76

Leaving aside the issue of whether or not rare books were given away or put in dumpsters, It’s not confidence-building when the government minister can’t offer information about which books have been digitized and where they might located online.

Interestingly,  Fisheries and Oceans is not the only department/ministry shutting down libraries (from McDiarmid’s CBC article),

Fisheries and Oceans is just one of the 14 federal departments, including Health Canada and Environment Canada, that have been shutting physical libraries and digitizing or consolidating the material into closed central book vaults.

I was unaware of the problems with Health Canada’s libraries but Laura Payton’s and Max Paris’ Jan. 20, 2014 article for CBC news online certainly raised my eyebrows,

Health Canada scientists are so concerned about losing access to their research library that they’re finding workarounds, with one squirrelling away journals and books in his basement for colleagues to consult, says a report obtained by CBC News.

The draft report from a consultant hired by the department warned it not to close its library, but the report was rejected as flawed and the advice went unheeded.

Before the main library closed, the inter-library loan functions were outsourced to a private company called Infotrieve, the consultant wrote in a report ordered by the department. The library’s physical collection was moved to the National Science Library on the Ottawa campus of the National Research Council last year.

“Staff requests have dropped 90 per cent over in-house service levels prior to the outsource. This statistic has been heralded as a cost savings by senior HC [Health Canada] management,” the report said.

“However, HC scientists have repeatedly said during the interview process that the decrease is because the information has become inaccessible — either it cannot arrive in due time, or it is unaffordable due to the fee structure in place.”

….

The report noted the workarounds scientists used to overcome their access problems.

Mueller [Dr. Rudi Mueller, who left the department in 2012] used his contacts in industry for scientific literature. He also went to university libraries where he had a faculty connection.

The report said Health Canada scientists sometimes use the library cards of university students in co-operative programs at the department.

Unsanctioned libraries have been created by science staff.

“One group moved its 250 feet of published materials to an employee’s basement. When you need a book, you email ‘Fred,’ and ‘Fred’ brings the book in with him the next day,” the consultant wrote in his report.

“I think it’s part of being a scientist. You find a way around the problems,” Mueller told CBC News.

Unsanctioned, underground libraries aside, the assumption that digitizing documents and books ensures access is false.  Glyn Moody in a Nov. 12, 2013 article for Techdirt gives a chastening example of how vulnerable our digital memories are,

The Internet Archive is the world’s online memory, holding the only copies of many historic (and not-so-historic) Web pages that have long disappeared from the Web itself.

Bad news:

This morning at about 3:30 a.m. a fire started at the Internet Archive’s San Francisco scanning center.

Good news:

no one was hurt and no data was lost. Our main building was not affected except for damage to one electrical run. This power issue caused us to lose power to some servers for a while.

Bad news:

Some physical materials were in the scanning center because they were being digitized, but most were in a separate locked room or in our physical archive and were not lost. Of those materials we did unfortunately lose, about half had already been digitized. We are working with our library partners now to assess.

That loss is unfortunate, but imagine if the fire had been in the main server room holding the Internet Archive’s 2 petabytes of data. Wisely, the project has placed copies at other locations …

That’s good to know, but it seems rather foolish for the world to depend on the Internet Archive always being able to keep all its copies up to date, especially as the quantity of data that it stores continues to rise. This digital library is so important in historical and cultural terms: surely it’s time to start mirroring the Internet Archive around the world in many locations, with direct and sustained support from multiple governments.

In addition to the issue of vulnerability, there’s also the issue of authenticity, from my June 5, 2013 posting about science, archives and memories,

… Luciana Duranti [Professor and Chair, MAS {Master of Archival Studies}Program at the University of British Columbia and Director, InterPARES] and her talk titled, Trust and Authenticity in the Digital Environment: An Increasingly Cloudy Issue, which took place in Vancouver (Canada) last year (mentioned in my May 18, 2012 posting).

Duranti raised many, many issues that most of us don’t consider when we blithely store information in the ‘cloud’ or create blogs that turn out to be repositories of a sort (and then don’t know what to do with them; ça c’est moi). She also previewed a Sept. 26 – 28, 2013 conference to be hosted in Vancouver by UNESCO (United Nations Educational, Scientific, and Cultural Organization), “Memory of the World in the Digital Age: Digitization and Preservation.” (UNESCO’s Memory of the World programme hosts a number of these themed conferences and workshops.)

The Sept. 2013 UNESCO ‘memory of the world’ conference in Vancouver seems rather timely in retrospect. The Council of Canadian Academies (CCA) announced that Dr. Doug Owram would be chairing their Memory Institutions and the Digital Revolution assessment (mentioned in my Feb. 22, 2013 posting; scroll down 80% of the way) and, after checking recently, I noticed that the Expert Panel has been assembled and it includes Duranti. Here’s the assessment description from the CCA’s ‘memory institutions’ webpage,

Library and Archives Canada has asked the Council of Canadian Academies to assess how memory institutions, which include archives, libraries, museums, and other cultural institutions, can embrace the opportunities and challenges of the changing ways in which Canadians are communicating and working in the digital age.

Background

Over the past three decades, Canadians have seen a dramatic transformation in both personal and professional forms of communication due to new technologies. Where the early personal computer and word-processing systems were largely used and understood as extensions of the typewriter, advances in technology since the 1980s have enabled people to adopt different approaches to communicating and documenting their lives, culture, and work. Increased computing power, inexpensive electronic storage, and the widespread adoption of broadband computer networks have thrust methods of communication far ahead of our ability to grasp the implications of these advances.

These trends present both significant challenges and opportunities for traditional memory institutions as they work towards ensuring that valuable information is safeguarded and maintained for the long term and for the benefit of future generations. It requires that they keep track of new types of records that may be of future cultural significance, and of any changes in how decisions are being documented. As part of this assessment, the Council’s expert panel will examine the evidence as it relates to emerging trends, international best practices in archiving, and strengths and weaknesses in how Canada’s memory institutions are responding to these opportunities and challenges. Once complete, this assessment will provide an in-depth and balanced report that will support Library and Archives Canada and other memory institutions as they consider how best to manage and preserve the mass quantity of communications records generated as a result of new and emerging technologies.

The Council’s assessment is running concurrently with the Royal Society of Canada’s expert panel assessment on Libraries and Archives in 21st century Canada. Though similar in subject matter, these assessments have a different focus and follow a different process. The Council’s assessment is concerned foremost with opportunities and challenges for memory institutions as they adapt to a rapidly changing digital environment. In navigating these issues, the Council will draw on a highly qualified and multidisciplinary expert panel to undertake a rigorous assessment of the evidence and of significant international trends in policy and technology now underway. The final report will provide Canadians, policy-makers, and decision-makers with the evidence and information needed to consider policy directions. In contrast, the RSC panel focuses on the status and future of libraries and archives, and will draw upon a public engagement process.

So, the government is shutting down libraries in order to save money and they’re praying (?) that the materials have been digitized and adequate care has been taken to ensure that they will not be lost in some disaster or other. Meanwhile the Council of Canadian Academies is conducting an assessment of memory institutions in the digital age. The approach seems to backwards.

On a more amusing note, Rick Mercer parodies at lease one way scientists are finding to circumvent the cost-cutting exercise in an excerpt (approximately 1 min.)  from his Jan. 29, 2014 Rick Mercer Report telecast (thanks Roz),

Mercer’s comment about sports and Canada’s Prime Minister, Stephen Harper’s preferences is a reference to Harper’s expressed desire to write a book about hockey and possibly a veiled reference to Harper’s successful move to prorogue parliament during the 2010 Winter Olympic games in Vancouver in what many observers suggested was a strategy allowing Harper to attend the games at his leisure.

Whether or not you agree with the decision to shutdown some libraries, the implementation seems to have been a remarkably sloppy affair.

Canada-US Regulatory Cooperation Council’s Nanotechnology Work Plan

Thanks for Lynn L. Bergeson for her Dec. 1, 2012 posting on the Nanotechnology Now website for the information about a Nov. 28, 2012 webinar that was held to discuss a Nanotechnology Work Plan developed by the joint Canada-US Regulatory Cooperation Council (or sometimes it’s called the US-Canada Regulatory Cooperation Council),

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

To compare risk assessment and risk management practices to highlight and identify best practices, data gaps, and differences between the two jurisdictions, the RCC sought nominations of a nanomaterial substance for a case study. Four nanomaterial substances were nominated: multiwall carbon nanotubes, nanocrystalline cellulose, nano silver, and titanium dioxide. The RCC has selected multiwall carbon nanotubes for the case study. The RCC intends to hold in March 2013 a workshop in Washington, D.C., to discuss information collected to date and approaches moving forward. In spring 2013, the RCC will hold one or two conference calls or webinars to discuss information gathered between countries and the path forward. Finally, in fall 2013, the RCC expects to hold a stakeholder consultation/workshop on results to date.

Here’s some background on the RCC. First announced in February 2011, the RCC had its first ‘stakeholder’ session (attended by approximately 240)  in January 2012 in Washington, DC. where a series of initiatives, including nanotechnology, were discussed (from the US International Trade Administration RCC Stakeholder Outreach webpage),

Agriculture and Food, Session A

  • Perimeter approach to plant protection

Agriculture and Food, Session B

  • Crop protection products

Agriculture and Food, Session C

  • Meat/poultry – equivalency
  • Meat/poultry – certification requirements
  • Meat cut nomenclature

Agriculture and Food, Session D

  • Veterinary drugs
  • Zoning for foreign animal disease

Agriculture and Food, Session E

  • Financial protection to produce sellers

Agriculture and Food, Session F

  • Food safety – common approach
  • Food safety – testing

Road Transport – Motor Vehicles

  • Existing motor vehicle safety standards
  • New motor vehicle safety standards

Air Transport

  • Unmanned aircraft

Transportation

  • Intelligent Transportation Systems

Transportation

  • Dangerous goods means of transportation

Marine Transport

  • Safety and security framework & arrangement for the St. Lawrence Seaway & Great Lakes System
  • Marine transportation security regulations
  • Recreational boat manufacturing standards
  • Standard for lifejackets

Rail Transport

  • Locomotive Emissions
  • Rail Safety Standards

Environment

  • Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

  • Electronic submission gateway
  • Over-the-counter products – common monographs
  • Good manufacturing practices

Occupational Safety Issues

  • Classification & labelling of workplace hazardous chemicals

Nanotechnology

  • Nanotechnology

Led jointly by senior officials from Canada and the United States, the purpose of the various technical review sessions was to seek expert advice and technical input from the approximately 240 stakeholders in attendance.

Since the Jan. 2012 meeting, a Nanotechnology Work Plan has been developed and that’s what was recently discussed at the Nov. 28, 2012 webinar. I did find more on a Canadian government website, Canada’s Economic Action Plan Nanotechnology Work Plan webpage,

Nanotechnology Work Plan

 Canada Leads: Karen Dodds, Assistant Deputy Minister, Science and Technology Branch, Environment Canada (EC)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Health Canada (HC)

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome: Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.

Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

3-6 months:

Canada provides initial feedback on US “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.

6-12 months:

Countries complete an initial draft of shared principles for the regulation of nanomaterials.

12-18 months:

Update of draft principles informed from on-going stakeholder and expert consultations.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Countries complete final draft of shared principles for the regulation of nanomaterials.

Workplan for Industrial Nanomaterials

Priority-Setting: Identify common criteria for determining characteristics of industrial nanomaterials of concern/no-concern

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/US review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials [Canada is a lead in the OECD Working Party on Manufactured Nanomaterials]).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Initiate an analysis of characteristics of select nanomaterials: similarities, differences, reasons for them.

Initiate discussions on approaches to consider for common definitions and terminology.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Develop draft criteria for determining characteristics of industrial nanomaterials of concern/no-concern.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

Here’s information for the leads should you feel compelled to make contact,

Canada

(Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada ([email protected]; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch ([email protected]; ph. 613-946-6701)

United States

(Lead) Margaret Malanoski, Office of Management and Budget ([email protected])

I gather that the ‘stakeholders’ are business people, researchers, and policy analysts/makers as there doesn’t seem to be any mechanism for public consultation or education, for that matter.

A new standard (in Canada) for occupational exposure to engineered nanomaterials

The Oct. 31, 2012 announcement from the CSA (Canadian Standards Association?) Group (H/T to the Canadian Safety Reporter) is a bit skimpy on details but here goes,

CSA Group, a leading standards development, testing and certification organization officially announces Canada’s first adopted International Organization for Standardization (ISO) standard on nanotechnologies. CSA Z12885, Nanotechnologies – Exposure control program for engineered nanomaterials in occupational settings provides guidance for the safe use of nanomaterials in the workplace.

“The development of standards is crucial for effective and responsible commercialization of nanotechnologies,” said Brian Haydon, Senior Project Manager, Standards, CSA Group. “CSA Z12885 is the first in a series of standards on nanotechnologies being adopted in Canada, resulting from international and Canadian contributions to the continued activity of ISO/TC 229, the ISO Technical Committee on nanotechnologies.”

CSA Z12885, Nanotechnologies – Exposure control program for engineered nanomaterials in occupational settings provides guidance to establish and implement a comprehensive managed program to control exposure to nanomaterials in the workplace. This follows recognized approaches to risk management with a focus on information and issues specific to nanotechnologies including hazard identification, risk assessment procedures, training requirements and worker engagement. CSA Z12885 contains revisions to ISO/TR 12885 and additional guidance to reflect Canadian practices and safety considerations.

It’s interesting to note which agencies offered financial support to develop this CSA Z12885 standard,

This standard was announced to industry and research stakeholders at the recent Nano Ontario 2012 Conference in Waterloo, Ontario, Canada. The development of this Standard was made possible, in part, by the financial support of Alberta Innovates Technology Futures – nanoAlberta, Health Canada, MDEIE (Developpement economique, Innovation et Exportation – Gouvernement du Quebec) and the National Research Council Canada – Industrial Research Assistance Program.

I first mentioned this standard in my June 12, 2012 posting about the OECD (Organization for Economic Cooperation and Development) and Canada’s report regarding its nanotechnology initiatives,

4. Information on any Developments Related to Good Practice Documents.

A. The Canadian Standards Association (CSA) Technical Committee on Nanotechnologies – Occupational Health and Safety has completed a draft national standard (CSA Z12885) to provide guidance for workers, entitled “Nanotechnologies — Exposure control program for engineered nanomaterials in occupational settings” This document is largely based on the published international ISO Technical Report, ISO/TR 12885:2008 entitled “Health & Safety Practices in Occupational Settings relevant to Nanotechnologies”. The CSA Z12885 standard has completed the public review process and is proceeding to ballot, with completion anticipated in mid-2012.

B. Government, industry, research, user, and consumer interests are participating as designated experts from Canada on international standards development through the Canadian Advisory Committee to International Organization for Standardization/Technical Committee 229 (ISO/TC229) Nanotechnologies, facilitated by CSA Standards. This includes active participation on terminology, nomenclature, measurement, characterization, material specification and health, safety, environmental aspects of nanotechnologies standards under development.

They’ve been working on this standard for at least two years as I first mentioned it in a Sept. 24, 2012 posting about earlier OECD report on Canada’s nanotechnology initiatives.

TAPPI 2012 nanotechnology conference in Canada

This coming Monday, June 4 to Thursday, June 7, 2012, the Nanotechnology for Renewable Materials conference (2012 TAPPI [Technical Association of the Pulp and Paper Industry] International Conference) will be taking place in Montréal, Québec.

As one might expect, there’s going to be a major emphasis on nanocrystalline cellulose (NCC) and Celluforce’s new NCC production plant in Windsor, Québec. Keynote speakers for the conference include (from the Keynote Speakers webpage),

Dr. Dylan J. Boday
Advisory Engineer Team Lead
IBM’s Materials Engineering Laboratory

Dr. Dylan J. Boday is the Advisory Engineer Team Lead for IBM’s Materials Engineering Laboratory. In this role, he leads efforts across multiple divisions to advance technological capabilities and enhance product performance.

Dylan’s research at IBM focuses on creating inventive pathways toward the development of polymers, composites, surface science, nanoparticles and hybrid materials. He has organized several strategic partnerships to leverage new materials development that align with specific business needs for IBM. He also established and now leads a global team focused on the sustainability of IBM’s products and is the co-lead of an upcoming international conference that will focus on the advances and challenges of sustainable materials.

As a member of the American Chemical Society Polymer Board, he provides leadership to the broader polymer science field. His technical contributions have led to more than 30 patent filings in the areas of electrostatic discharge and thermally conductive composites, functional nanomaterials and printed circuit board materials. He also has numerous published articles on composites, self healing materials and anti-corrosion coatings, in addition to serving as a reviewer for several scientific journals. In 2011, he was named an IBM Master Inventor and is a member of the IBM Smarter Planet invention review board.

Dylan holds a bachelor’s degree in Chemistry and a doctorate degree in Materials Engineering from the University of Arizona.

Jean Moreau
President and Chief Executive Officer
CelluForce

As President and CEO of CelluForce since February 2011, Jean Moreau brings a wealth of experience in finance, operations and business development which he acquired in both private and public corporations, in various fields including manufacturing, entertainment, distribution and consumer goods.

A chartered accountant for over 10 years at Arthur Andersen and Co., Mr. Moreau was responsible for the acquisition of numerous large companies and plants.

Among others, he headed financial and production planning teams as Vice President of Finance, Paper Production sector and Vice President of Supply for Domtar. As Chief Financial Officer, he was also involved in the introduction of the Supremex Income Fund on the Toronto Stock Exchange, raising $300M in capital funding and, in addition was responsible for the implementation of a strategic business plan at Guess Canada, which was subsequently named one of Canada’s 50 Best Managed Companies.

As head of the CelluForce team, Jean wished to promote, within several sectors of activity, the development of commercial applications related to NCC around the world, thus ensuring the company’s manufacturing and commercial growth.

Jean Hamel, Eng.
Vice President
FPInnovations

Jean Hamel, Eng., Vice President, FPInnovations, received his B.Sc. (1983), and M. Eng. (1985), in Mechanical Engineering from the University of Sherbrooke. He joined Pulp and Paper Research Institute of Canada (Paprican) as a Research Engineer to work on the technical development, optimization and troubleshooting of paper finishing equipment.

In 1995 he joined St-Laurent Paperboard as a Senior Process Engineer to work on product development, paper machine optimization and start-up of new finishing equipment. In 1996, he returned to Paprican where he led the construction of the pilot paper machine and developed the new Roll Testing Facility, the first business unit concept of the organization. In 2004 he became Manager of the Product Performance Program. Soon after merging of three research institutes (Paprican, Forintek, FERIC) to form FPInnovations in 2007, he was named the Director of Research for the Pulp & Paper Division of FPInnovations where he focused on accelerating the technology transfer and developing new innovation processes.

Since 2009 he has been the Vice President of FPInnovations, leading the innovation program on pulp and paper and shifting the R&D effort to develop new chemicals, biomaterials and composites from wood fibers. He currently sits on the boards of CelluForce, a Domtar-FPInnovations joint venture on nanocrystalline cellulose (NCC) production, Sustainable Chemistry Alliance (SCA), ICGQ, ADRIQ and NSERC Green Fiber Network.

Andy Atkinson
Manager, Emerging Sciences Policy
Policy, Planning and Coordination Division
Strategic Policy Branch
Health Canada

Andrew Atkinson is currently Manager of the Emerging Science Policy group under the Strategic Policy Branch of Health Canada.

Andrew is currently overseeing coordination of science policy issues across the various regulatory and research programs under the mandate of Health Canada. Prior to Health Canada, he was a manager under Environment Canada’s CEPA new chemicals program, where he oversaw chemical and nanomaterial risk assessments, as well as the development of risk assessment methodologies.

In parallel to domestic work, he has been actively engaged in ISO and OECD nanotechnology efforts, including co-chairing groups on nomenclature of nano-objects under ISO TC229.

It seems more heavily weighted towards Canadian keynote speakers with, as I hinted earlier,  a special nod to CelluForce. I did glance through the full conference programme and see that there is  healthy representation internationally (Hungary, China, Finland, US, Sweden, Japan, Alberta [sometimes that province does seem like a separate country],  etc.).

After hearing a murmur about developing standards for nanocellulose at the Feb. 2012 annual meeting of the American Association for Advancement of Science (AAAS), I was excited to find this on on p. 8 of the conference programme,

The success of the 2011 Workshop on International Standards for Nancellulose has resulted in writing of the Roadmap for the Development of International Standards for Nanocellulose (Draft 4). Since then TAPPI has formed the International Nanocellulose Standards Coordination Committee (INSCC) in its Nanotechnology Division to house and coordinate the execution of the Roadmap. The 2012 Workshop on International Standards for Nancellulose will bring workshop participants up-to-date on nanocellulose standards activities since the completion of the Roadmap (Draft 4), initiate coordination activities in several areas of nanocellulose standards development, and if necessary, discuss revisions to the Roadmap.

Perhaps one of these days they’ll have a final version of their Roadmap.

I last mentioned this annual conference in my Sept. 24, 2009 posting when it was held in Alberta and made passing references to the 2010 edition in Finland during an interview (my Aug. 27, 2010 posting) with Dr. Richard Berry of FPInnovations and to the 2011 edition in Washington, DC in my June 6, 2011 posting about the formation, by Domtar and FPInnovations, of CelluForce.

As for the 2012 edition, I wonder if they considered inviting Janelle Tam, the 16 year old student who won a national award for her work on a new application for NCC (my Disease-fighting and anti-aging with nanocrystalline cellulose (NCC) and Janelle Tam posting on May 11, 2012) to this conference. In any event, her national win entitled her to compete for an international award in Boston, Massachusetts June 18, 2012.

Nanoparticle size doesn’t matter

Does size matter when regulating nanomaterials? As I’ve noted (more than once), I waffle on this issue. Earlier this week, I featured my thoughts on Health Canada’s definition of nanomaterial (Oct. 24, 2011)  and posted an interview with Dr. Andrew Maynard (Oct. 24, 2011) where he expressed reservations about basing nanomaterial regulations on definitions which rely on  nanoparticle size.

Hours after posting my thoughts and the interview with Andrew, I came across this Oct. 24, 2011 news item on Nanowerk titled, Nanoparticles and their size may not be big issues. From the news item,

If you’ve ever eaten from silverware or worn copper jewelry, you’ve been in a perfect storm in which nanoparticles were dropped into the environment, say scientists at the University of Oregon.

Since the emergence of nanotechnology, researchers, regulators and the public have been concerned that the potential toxicity of nano-sized products might threaten human health by way of environmental exposure.

Now, with the help of high-powered transmission electron microscopes, chemists captured never-before-seen views of miniscule metal nanoparticles naturally being created by silver articles such as wire, jewelry and eating utensils in contact with other surfaces. It turns out, researchers say, nanoparticles have been in contact with humans for a long, long time. [emphasis mine]

“Our findings show that nanoparticle ‘size’ may not be static, especially when particles are on surfaces. For this reason, we believe that environmental health and safety concerns should not be defined — or regulated — based upon size,” said James E. Hutchison, who holds the Lokey-Harrington Chair in Chemistry. [emphasis mine] “In addition, the generation of nanoparticles from objects that humans have contacted for millennia suggests that humans have been exposed to these nanoparticles throughout time. Rather than raise concern, I think this suggests that we would have already linked exposure to these materials to health hazards if there were any.”

This discussion is becoming quite interesting.